Applications for regulatory approval to be submitted starting mid-2017
PUBLIC HEALTH PATHWAY
Open-label studies to provide the ring to women of reproductive age, support consistent use and collect additional safety data
Dapivirine ring becomes the first microbicide to show efficacy in two Phase III trials
In early 2016, IPM’s monthly dapivirine ring was found to safely help reduce HIV risk in two Phase III trials — making it the first microbicide and the first long-acting prevention product to confirm efficacy.
The ring was found to safely reduce infection among more than 4,500 women in Malawi, South Africa, Uganda and Zimbabwe by approximately 30 percent overall. Additional analyses showed that HIV risk reduction was greater among women who used the ring consistently.
• Vaginal ring made from flexible silicone
• Slowly releases ARV drug dapivirine
• Self-inserted monthly
• Assessed for safety and efficacy in The Ring Study, led by IPM, and ASPIRE, led by the US National Institutes of Health-funded Microbicide Trials Network (MTN)
Building the HIV prevention evidence base
IPM and MTN published primary Ring Study and ASPIRE results, respectively, in the New England Journal of Medicine, and jointly announced the findings at a press conference and sessions at the 2016 Conference on Retroviruses and Opportunistic Infections in Boston. IPM presented on dapivirine ring research at major scientific conferences throughout the year, including the 2016 International AIDS Conference (AIDS 2016) in Durban and the 2016 HIV Research for Prevention (R4P) Conference in Chicago.
SPREADING THE WORD
IPM and MTN gathered Phase III participants, trial communities and civil society advocates to share the results and our plans for open-label follow-on studies now ongoing in the four Phase III countries.
To increase public awareness of the dapivirine ring results and the role the ring could play in broadening the toolkit for women’s HIV prevention, IPM conducted briefings for stakeholders across Africa, Europe and North America, and hosted events at the Women Deliver conference in Copenhagen and the United Nations High-level Meeting on HIV and AIDS in New York.
IPM was also a sponsor of the inaugural Women Now! conference to elevate women’s sexual and reproductive health and rights and justice issues in the lead-up to AIDS 2016.
PATHWAYS TO ACCESS FOR THE RING